Class I U.S. Food and Drug Administration

True Metrix Blood Glucose Monitoring Systems recall: As currently written, the Owner’s Booklets/System Instructions for Use fails

Recall published 9 months ago

As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.

True Metrix Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1545-2026, Z-1546-2026, Z-1547-2026, Z-1548-2026
Published
February 6, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
True Metrix
Product type
Medical devices
Units affected
12,067,458; 1,001,534; 3,678,026
Distribution
Florida
Lot / code info
Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940. International: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior, TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior, McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior, McKesson Med Surg TRUE METRIX PRO Owners… — Device Item/UDI-DI: RE4H01P-40/21292006099, RE4H01P-43/21292006105, RE4212P-00/10840330705681, RE4099P-40/21292014919, RE4099P-43/21292008673, RE4051P-00/20612479197217, RE4068P-01/607415261097. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX PRO Owners Booklet/RE4TVHP03 Rev 56 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, Device serial numbers: Prefix "TP" followed by a seven-digit numeric sequence. — Device Item/UDI-DI: REA4001-01/311917173894, REA4002-01/96295129267, REA4007-01/50428354766, REA4011-01/87701427398, REA4019-01/708820685659, REA4020-01/41415072787, REA4025-01/93351022784, REA4031-01/41220009169, REA4054-01/10939742445, REA4066-01/11822590051, REA4081-01/21292015015, REA4081-40/21292007164, REA4081-43/21292007584, REA4089-01/52569139042, REA4094-01/681131240154, REA4094-01RX/681131403214, REA4203-01/41260007354, REA4211-01/10939958617, REA4H01-01/21292007010, REA4H01-40/21292007447, REA4H01-43/21292007911, International: REA4i03-01/N/A, REA4i03-02/N/A, REA4i04-00/21292012731, REA4i81-11/N/A, REA4i82-11/21292012212, REA4i82-12/21292009991. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX AIR Owner's Booklet/ REA4TVH03 Rev 57 and prior, TRUE METRIX AIR Owner's Booklet (English)/ REA4TVH35 Rev 51 and prior, TRUE METRIX AIR Owner's Booklet (Spanish)/ REA4TVH35S Rev 51 and prior, Relion (Walmart) TRUE METRIX AIR Owners Booklet/ REA4RLN03 Rev 52 and prior, Relion (Walmart) TRUE METRIX AIR Owner's Booklet - English/ REA4RLN35 Rev 52 and prior, TRUE METRIX AIR Owner's Booklet International Trividia House Brand/ REA4ITV03 Rev 55 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health UK Limited/ REA4UKT03 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX AIR Owners Booklet/ REA4LAT03 Rev 51 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health Australia/ REA4AUT03 Rev 58 and prior. Device serial numbers: Prefixes "TB" or "TA"… — Device Item/UDI-DI: RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793. International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior, TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE…
UPC codes
00311917166896, 713733069816, 20612479197231, 321130788669, 725439988933, 10840330705681, 20612479197217, 311917173894, 708820685659, 681131240154, 681131403214, 311917178691, 708820721098

Products covered by this recall

Blood Glucose Monitoring Systems

What the company announced

(FT. LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems (collectively, the “Products”) distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean.

Trividia is updating the E-5 Error Code in the “Messages” section of the Owner’s Booklets/System Instructions for Use to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose .

The system displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.

Since August 2014, when TRUE METRIX was launched globally, there have been 114 reported serious injuries, and one (1) death associated with the E-5 Error Code.

UPDATED E-5 INSTRUCTIONS for TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO:

  • Display: SEE IMAGE BELOW · Reason: Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error · Action: WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

UPDATED E-5 INSTRUCTIONS for TRUE METRIX PRO:

  • Display: SEE IMAGE BELOW · Reason: Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error · Action: WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

If you have any questions relating to the Owner’s Booklets/System Instructions for Use update, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday - Friday 8AM-8PM EST (excluding holidays) or e-mail [email protected] or visit www.trividiahealth.com/E-5productnotice .

The correction affects all TRUE METRIX branded Blood Glucose Meters distributed in the United States, United Kingdom, Mexico, Australia and the Caribbean. This includes our cobranded products sold under store or distribution partner names. Please refer to the Product Notice located at www.trividiahealth.com/E-5productnotice for more information on the list of co-brand partners and affected product labeling.

The company is sending the Product Notice to impacted customers with instructions on what to do, to post the notice where products are stored/sold, and to forward the notice to device users, if possible. These customers include pharmacies, mail order companies, and distributors where the TRUE METRIX® meters are sold. Please refer to the Product Notice located at www.trividiahealth.com/E-5productnotice for more information.

You may continue to use the TRUE METRIX® Products . Products are not to be returned or replaced. This correction does not require removal of the Products from where they are used or sold. This labeling correction impacts the Owner’s Booklets/System Instructions for Use that accompany the meters at purchase, as well as the online labeling and help guides located on Trividia Health’s website. Trividia Health will notify users of additional mitigation strategies as needed.

Trividia Health has notified the U.S. Food and Drug Administration (FDA) of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Patient safety is our top priority, and we apologize for any inconvenience this correction may cause you.

About Trividia Health

Trividia Health, Inc., is a global health and wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced performance products for people with diabetes. With products sold under TRUE and store brand labels, the company is the exclusive partner and supplier of affordable, high-quality blood glucose monitoring and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service providers. For more information, please visit: www.TrividiaHealth.com .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 18 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00311917166896
  • 713733069816
  • 20612479197231
  • 321130788669
  • 725439988933
  • 10840330705681
  • 20612479197217
  • 311917173894
  • 708820685659
  • 681131240154
  • 681131403214
  • 311917178691
  • 708820721098

Model or item number

On the rating label, the box or the instruction sheet.

  • RE4001-01
  • RE4H01P-40
  • REA4001-01
  • RF4001-01BK

Package size

Match the net weight or the piece count on the front of the pack.

  • 600 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

True Metrix — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Trividia Health, Inc. — Consumers: Trividia Health Customer Care Department, 1-888-835-2723 — Media: Annmarie Ramos, (800) 342-7226, ext. 3190

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was True Metrix medical devices recalled?

As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00311917166896, 713733069816, 20612479197231; model number RE4001-01, RE4H01P-40, REA4001-01. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Florida.

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